GMP Production Manager - Sterile
Dalton Pharma Services is a leading provider of integrated pharmaceutical discovery, development and manufacturing services to the biotechnology and pharmaceutical industries. Dalton offers industry leading expertise in chemical synthesis, API production, formulation development and the manufacturing of sterile drug products, combined with extensive in-house analytical and quality support. We bring over 30 years of experience to our client’s projects with an emphasis on quality, speed and flexibility.
We are currently looking for an experienced GMP Production Manager for our growing sterile drug product manufacturing division. The role requires extensive experience in aseptic processing and manufacturing of sterile products, strong organizational and management skills for coordinating people, equipment, materials and documentation. It also requires a strong desire to lead, support and inspire a team of dedicated professionals.
As the head of the sterile team for GMP Production, the Manager will be responsible for the overall operation of the department.
The successful candidate should meet the following qualifications and requirements.
Qualifications and Requirements
- Must be focused, task driven, and committed to timely completion of projects in a fast paced and technically challenging environment.
- A thorough knowledge and understanding of cGMPs, experience with regulatory inspections, including Health Canada and US FDA.
- Sound knowledge and understanding of aseptic processing requirements, cleanroom operations, and best practice for sterile manufacturing.
- Familiar with common technology in aseptic processing, sterilization method, and manufacturing technology.
- Proven track record of leading a high performing production team, including scheduling team workloads, setting priorities and meeting deadlines.
- Strong Quality and risk-based approach decision making.
- Provide leadership, coaching and mentoring to technical staffs.
- Strong verbal and written communication skills.
- Hold a science degree in chemistry or related fields, must have Microbiology courses at university level. Major in Microbiology is an asset.
- At least 10 years’ experience in a pharmaceutical industry, including at least 5 years at management level and directly involved in sterile manufacturing.
We offer a competitive salary and benefits, as well as an excellent opportunity to build your career with a well-established company.
Please forward your resume to:
Human Resources E-mail: careers@dalton
While we appreciate all applications received, only those selected for an interview will be contacted.
Job Types: Full-time, Permanent
Pay: $85,000.00-$100,000.00 per year
Benefits:
- Casual dress
- Dental care
- Disability insurance
- Employee assistance program
- Extended health care
- Flexible schedule
- Life insurance
- On-site parking
- RRSP match
- Tuition reimbursement
- Vision care
- Wellness program
Flexible language requirement:
Schedule:
Application question(s):
- Do you live in the Toronto Area? GTA
- Have you completed Microbiology courses at university level.
Education:
- Bachelor's Degree (preferred)
Experience:
- supervision/management position: 5 years (preferred)
- cleanroom operations for sterile manufacturing: 10 years (preferred)
- Canadian GMPs, FDA GMPs: 10 years (preferred)
- aseptic processing requirements: 5 years (required)
Work Location: In person
